Human Research Ethics Standard Operating Procedure

1.           Meetings

1.1         Timing

UNE HREC will meet monthly between February and December. Meeting dates and agenda closing date will be published in a timely manner on the Human Research Ethics website. HREC will provide responses to applications within 14 to 28 days. Ideally investigators should provide HREC with their applications well ahead of research start dates to avoid missing deadlines.

1.2         Quorum

The quorum for meetings is a majority of the members. Where there is less than full attendance at a HREC meeting, the Chair must be satisfied that, before a decision is reached, members have received all papers, have had an opportunity to contribute their views and have had their views considered and recorded. This is consistent with the requirements of Section 5.2.32 of the National Statement on the Ethical Conduct of Human Research 2007 (Updated 2018) (hereafter National Statement)

1.3         Electronic attendance

If the Committee is satisfied that it is otherwise impossible for a member to attend a HREC meeting in person, the Chair may approve attendance through Zoom, Skype or other ICT platform.

1.4 Submission of comments/conditions in absentia

Where electronic attendance may not be an option for a member who is unable to attend, the member may submit comments and recommendations with conditions on the meeting’s business to the HREC via the human ethics email address (humanethics@une.edu.au) before the close of the meeting.

1.5         HREC Visitors

UNE HREC may invite applicants for ethics approval or other persons to attend HREC meetings as visitors for particular items of business, or for complete meetings. Visitors have no speaking rights, unless asked by the Chair of HREC.

1.6         Agreement

UNE HREC will endeavour to reach a decision by general agreement. This need not involve unanimity (National Statement 5.2.33)

2.           Advisory Group

The DVC-R may convene senior academic staff with significant research experience as an advisory group (the Human Research Ethics Advisory Group – HREAG) to advise and comment on matters put to it by the DVC-R or the Chair of HREC.

HREAG can meet at least every trimester; further meetings would be at the discretion of the DVC-R, the HREC Chair or at the request of HREAG.

3.            Procedures for managing low/negligible risk applications

A sub-Committee of HREC will meet as required to assess low-risk research ethics applications and review Variations, Progress Reports and Final Reports of approved research projects. This sub-Committee will comprise of the Chair, at least one Human Research Ethics Officer, and one Deputy Chair of HREC, or other members at the discretion of the Chair of HREC, in order to facilitate timely responses to ethics applications. Where there is less than full attendance at a sub-Committee of HREC meeting, the Chair must be satisfied that, before a decision is reached, members have received all papers, have had an opportunity to contribute their views and have had their views considered and recorded.

Decisions of the sub-Committee will be reviewed and ratified by the HREC at its regular meeting.

4.           Fees

4.1         Appointees of UNE

There is no fee for applications submitted to the HREC by researchers who are full-time, part-time or conjoint UNE appointees.

4.2         Researchers without UNE affiliation

The HREC may charge a fee for reviewing applications from researchers who have no formal affiliation with UNE. These researchers will also be required to sign a contract with UNE detailing the terms and conditions for HREC to review the application and monitor the research.

5.           Managing external and multi-centre review

5.1         External ethical review

Consistent with the National Statement, UNE HREC will recognise approvals issued by other NHMRC-registered HRECS and their delegated review bodies. UNE staff and students therefore do not have to apply for UNE HREC review. The lead UNE researcher will, however, be required to provide to UNE HREC evidence of the external review and approval. Further the lead UNE researcher will be required to provide the HREC with all and any Progress Reports, Variation requests and Final Reports and well as report any behaviour, activity or incidents thay may cause harm to researchers and/or participants or put UNE at risk.

5.2         Exception for non-registered HRECs

UNE HREC review is still required where the external HREC or review body is not registered with the NHMRC.

5.3         Multi-centre review

Where an external HREC or other review is unable to approve UNE as a research site for specific study activities, UNE HREC will review the application.

6.           Managing research overseas

6.1         UNE HREC approved research

UNE HREC approval is required for UNE researchers who wish to conduct any level of research involving human participants overseas.

All research conducted overseas by all named researchers must comply with the National Statement (4.8.1). To fail to do is considered breach of Research Integrity and will be referred to a UNE Research Integrity Officer for investigation.

In reviewing a proposal, the UNE HREC will be mindful of specific considerations for overseas research in the National Statement (See Chapter 4.8 of the National Statement).

6.2         Care, supervision and communication

UNE HREC strongly requires that all UNE research students are adequately supervised and supported when working with human participants both nationally and overseas. Specifically HREC believes particular care needs to be taken in countries that are politically unstable, or where human rights are restricted, and/or where the research involves participants who are economically disadvantaged, exploited or marginalised.

The Committee will require researchers conducting research overseas to nominate an in-country supervisor or contact point and outline a communications plan covering the research student while they are overseas and their supervisor in Australia.

UNE HREC will also require researchers to produce certified evidence of translation of project documents (information for participants, consent forms and surveys), an assessment of the need for interpreters and strategies for meeting that need.

6.3         UNE Researchers working overseas with overseas approval

UNE HREC will require UNE researchers who intend to participate in human research that has been approved overseas need to provide evidence of review and approval by the relevant overseas body.

UNE HREC reserves the right to request that the overseas approval meets the requirements of the National Statement.

7.           Recording and reporting

7.1         Notice of terms of reference

The UNE HREC’s terms of reference are publicly available on the Human Ethics website.

7.2.        HREC Activity

The delegation of tasks by Ethics and Research Integrity Officers will be determined by the Chair to ensure clear reporting and governance processes and procedures are maintained. Ethics and Research Integrity Officers will be required to maintain all written records of all UNE HREC’s activities, including agendas and minutes of all HREC meetings as required by the Chair in compliance with University policy. Further all Ethics and Research Integrity Officers will abide by the UNE Code of Conduct. A failure to comply with any rule of Code of Conduct, as considered by the Chair of HREC, may amount to misconduct/serious misconduct and/or unsatisfactory performance.

7.3         Filing applications

All Human Research Ethics Officers will prepare and maintain an electronic file for each application and include copies of relevant correspondence between HREC and the applicant.

7.4         Storage and security of records

All records will be kept securely and confidentially in accordance with the requirements of the Records and Information Privacy Act 2002 and the UNE policy on the storage and retention of research data; the minimum period being seven (7) years retention from the date of completion for proposals and 15 years for clinical trials.

7.5         UNE reporting

The University HREC will provide periodic reports to the DVC-R and relevant bodies as requested (at the discretion of the Chair of HREC), including information on membership, meetings, the number of research proposals reviewed, complaints received and their outcomes, along with any other relevant matters.

7.6         NHMRC reporting

The UNE HREC will provide an honest and transparent Annual Report to the National Health and Medical Research Council.

8.           Monitoring research projects

UNE HREC monitors approved research projects to ensure compliance with the conditions of approval and to protect the rights, safety and welfare of participants. This includes review of annual progress reports and final reports, safety reports and reports of protocol violations. Audits will be conducted at the request of the Chair of HREC.

HREC has the discretion to adopt other appropriate mechanisms for monitoring depending on the complexity, design and risk perceived, including:

• Discussion of relevant aspects of the project with investigators, at any time;
• Random inspection of research sites, data, or consent documentation; and
• Interviews with research participants or other forms of feedback from them.

9.           Managing appeals and complaints

9.1         Appeals against rejection of an application

Where the UNE HREC has rejected an application an investigator may:

• Submit a new application, taking into account the HREC’s concerns or conditions; or
• Lodge an appeal with the HREC Chair, who will respond directly on the outcome of the appeal. An appeal must be lodge within 6 months of the rejection.
• If an investigator has been asked to resubmit an application (as opposed to it being rejected), they can only provide only one (1) resubmission. If the resubmission fails to meaningfully and substantively address HREC’s concerns and conditions, the application is rejected and a new application will need to be submitted.

9.2         Appeals against approval of an application

Where the HREC has approved an application and:

• An appellant subsequently identifies an ethical or scientific issue; or
• There were inconsistencies in the way the HREC applied policies and guidelines in reaching its decision;

the appellant may lodge an appeal with the Chair. The Chair will investigate the appeal and its validity and recommend to the HREC an appropriate course of action.

9.3         Complaints about the conduct of HREC or HREC members

Complaints against the HRE review process or the HRE Committee can be submitted in writing via email to a Human Research Ethics Officer. The submission should include details for the grounds of the complaint and the name and contact details of the complainant. The Chair will make a recommendation based on the evidence provided. If a resolution cannot be reached through internal processes, the complaint may be referred to an external agency or person upon mutual agreement by the parties concerned.

9.4         Complaints about the conduct of an approved research project

The Chair will consider complaints about the conduct of an approved research project, but if complaints include allegations of research conduct will refer them to the UNE Research Integrity Office to be dealt with under the UNE Procedures for Investigating Research Conduct Breaches or Related Complaints. The Research Integrity Office will inform the Chair of progress is assessing the complaint.

9.5         Record of complaints

HREC will keep a record of all complaints received, noting the outcome of the complaint or its referral.

10.         Review/Amendments to the HREC Terms of Reference

The Terms of Reference will be reviewed every three years and may be amended in consultation with the HREC and interested UNE parties.